Pearl Therapeutics' Phase 2b Results Show a 50% Improvement in Lung Function with PT003 Compared to SpirivaÃ‚® and ForadilÃ‚® in Patients with COPD
REDWOOD CITY, Calif., May 18, 2011 /PRNewswire/ -- Pearl Therapeutics Inc. presented detailed efficacy and safety results today from the Company's phase 2b study of PT003 (GFF MDI) in patients with moderate-to-very severe COPD during a late-breaker poster session at the annual meeting of the American Thoracic Society (ATS). PT003 is a proprietary fixed-dose combination of glycopyrrolate (GP), a long-acting muscarinic antagonist (LAMA), and formoterol fumarate (FF), an established, long-acting beta-2 agonist (LABA) delivered via a pressurized hydrofluoroalkane metered dose inhaler (HFA MDI). In addition to details of Pearl's Phase 2b primary endpoint, today's poster highlights findings from secondary endpoints that reinforce the superiority of PT003 over both of its individual components as well as market-leading active comparators in patients with moderate-to-very severe COPD. Top-line results from the primary endpoint of this study were disclosed in December 2010.
The study's primary endpoint was improvement in lung function after one week of dosing, as assessed by FEV1* AUC (0-12) relative to baseline at the start of treatment. Treatment with PT003 resulted in a statistically significant improvement in mean FEV1 AUC (0-12) of 47% (or 93 mL) over Foradil® and 49% (or 95 mL) over Spiriva® after one week of dosing (p<0.0001 for both comparisons).
"These results demonstrate an overwhelmingly superior outcome and an even larger degree of bronchodilation than our internal benchmark of 70 mL, providing what we believe to be a clinically meaningful benefit," noted Colin Reisner, MD, FCCP, FAAAAI, chief medical officer, and executive vice president of clinical development and medical affairs at Pearl Therapeutics. "While current COPD medications offer some relief, a significant need still exists f